A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk embolism thrombolysis study - Hi-PEITHO - S2479

Boston Scientific Corporation0 sites45 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•1\) Age 18\-80 years, inclusive
•2\) Objectively confirmed acute PE, based on CTPA showing a filling defect in at
•least one main or proximal lobar pulmonary artery (PA)
•3\) Elevated risk of early death/hemodynamic collapse, indicated by at least two
•of the following new\-onset clinical criteria:
•i) Electrocardiogram (ECG)\-documented tachycardia with heart rate \>\= 100 beats
•per minute, not due to hypovolemia, arrhythmia, or sepsis;
•ii) SBP \<\= 110 mm Hg for at least 15 minutes;
•iii) respiratory rate \> 20 x min\-1 or oxygen saturation on pulse oximetry
•(SpO2\) \< 90% (or partial arterial oxygen pressure \< 60 mmHg) at rest while

•1\) Hemodynamic instability\*, i.e. at least one of the following present:
•a) cardiac arrest or need for cardiopulmonary resuscitation;
•b) need for ECMO, or ECMO initiated before randomization;
•c) PE\-related shock, defined as: (i) SBP \< 90 mmHg, or vasopressors required to
•SBP \>\= 90 mmHg, despite an adequate volume status; and (ii) end\-organ
•hypoperfusion (altered mental status; oliguria/anuria; increased serum lactate);
•d) isolated persistent hypotension (SBP \< 90 mmHg, or a systolic pressure drop
•least 40 mmHg for at least 15 minutes), not caused by new\-onset arrhythmia,
•hypovolemia, or sepsis.
•\* Patients who presented with temporary need for fluid resuscitation and/or